(126 days)
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel
The system is intended for use by healthcare professionals.
The Interson USB Ultrasound Imaging System is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel.
The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function.
The Interson USB Ultrasound transducers operate in B-Mode, color Doppler, and combined mode (B + color Doppler), providing high resolution and high penetration performance. The product family uses curved and flat linear array transducers and includes a General Purpose (GP) probe and a Small Parts (SP) probe.
The SeeMore software application used in the Interson USB Ultrasound System supports static image acquisition and a cine function capable of storing up to 32 to 1024 sequential images. Management of patient history is enabled by the image or cine-storage function.
The SeeMore control software runs on standard Microsoft Windows platforms.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Interson USB Ultrasound System:
Summary of Acceptance Criteria and Device Performance:
Based on the provided document (K163443), the "acceptance criteria" are primarily established implicitly through compliance with recognized medical device standards and demonstrating substantial equivalence to predicate devices. There are no explicit quantitative performance metrics or threshold values listed as acceptance criteria in the manner typically seen for AI/ML device performance.
The device's performance is demonstrated through its successful compliance with these standards and the assertion that it introduces no new modes, features, or technologies requiring clinical testing beyond what is already "well-accepted" for predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by compliance/assertion) |
|---|---|
| Safety and Essential Performance (Electrical Safety) | Complies with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 for general requirements, and IEC 60601-2-37 (2015), Amendment 2 for specific requirements of ultrasonic medical diagnostic equipment. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 Edition 4.0 2014-02 for electromagnetic disturbances. |
| Acoustic Output | Complies with NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. |
| Usability | Complies with IEC 60601-1-6 Edition 3.1 2013-10 for usability. |
| Risk Management | Complies with ISO 14971 Second edition 2007-03-01 for application of risk management to medical devices. |
| Biocompatibility (Irritation and Skin Sensitization) | Complies with AAMI ANSI ISO 10993-10:2010/(R)2014 for tests for irritation and skin sensitization. |
| Biocompatibility (In Vitro Cytotoxicity) | Complies with AAMI ANSI ISO 10993-5:2009/(R)2014 for tests for in vitro cytotoxicity. |
| Equivalence of Intended Use/Indications for Use | The device's intended use and indications for use are substantially equivalent to predicate devices (Philips Lumify K152899 and Interson K070907), covering diagnostic ultrasound imaging in B, color Doppler, or Combined modes for specified applications (Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Urology, Gynecology, Pelvic Floor, Neuro-muscular, Peripheral Vessel). |
| Equivalence of Technological Characteristics | The device is comparable to predicate devices in areas such as modes of operation (B, color Doppler, combined), array geometry (curved and linear), mechanics (solid-state), software platform (commercial off-the-shelf OS), software control (standalone), and measurement functions (2D and area). The differences (e.g., lack of wireless networking, USB connector type) are deemed not to raise new questions of safety or effectiveness. |
| Clinical Safety and Effectiveness (Implicit Equivalence) | "The Interson USB Ultrasound System product family introduces no new modes, features, or technologies relative to the predicate devices... that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices." This implies that by being substantially equivalent to devices whose safety and effectiveness are established, the subject device also meets these criteria without requiring new clinical trials. |
Detailed Information about the Study:
The document describes a premarket notification (510(k)) submission for substantial equivalence, not a clinical study involving specific performance metrics for image interpretation or AI assistance. Therefore, many of the requested details about a "study" in the context of AI device evaluation are not applicable to this submission.
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Sample size used for the test set and the data provenance:
- N/A. This submission does not describe a clinical performance study with a test set of images or patient data to evaluate the device's diagnostic accuracy or performance against ground truth. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. As no clinical performance study with a test set was conducted for diagnostic accuracy, there were no experts used to establish ground truth in that context. The "ground truth" for this submission refers to compliance with established engineering and safety standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No test set or expert adjudication process for diagnostic performance was described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an ultrasound imaging system, not an AI-powered diagnostic assistance tool. Therefore, no MRMC study comparing human readers with or without AI assistance was conducted or is applicable. This submission predates widespread AI-driven medical imaging devices.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware/software system for ultrasound imaging, not a standalone AI algorithm. Its "performance" in the context of this submission is its ability to meet technical specifications and safety standards, and its equivalence to predicate devices, not its ability to make diagnostic interpretations without human involvement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance and safety testing, the "ground truth" is defined by the specifications and acceptable limits set forth in the referenced recognized standards (e.g., NEMA UD 2-2004, IEC 60601 series, ISO 14971, ISO 10993 series). The device was tested to ensure it met these technical parameters.
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The sample size for the training set:
- N/A. This device does not employ machine learning that would require a "training set" of data for an AI algorithm.
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How the ground truth for the training set was established:
- N/A. No training set for an AI algorithm was used.
In conclusion, the K163443 submission details a regulatory pathway demonstrating substantial equivalence for a traditional medical imaging device (ultrasound system) by showing compliance with recognized safety and performance standards and by comparing its technological characteristics and indications for use to already legally marketed predicate devices. It does not involve the type of clinical performance study or AI/ML evaluation detailed in the questions.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.